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Author: FDA Attorney

FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

Beverages, Dietary Supplements, Enforcement, Food, FTC, SubstantiationFTC

On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order …

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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

Dietary Supplements, Drug, Drugs, FDA, RecallsFDA

On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall …

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FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

510(k), CGMP, FDA, Medical Devices, Respiratory InfectionFDA

On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …

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FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week

Allergens, FDA, Food, Labeling, Recalls, Warning LettersFDA

This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer …

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FDA Warns of Recall Due to Undeclared Milk Derivatives in Several Beverage Products

Allergens, Beverages, FDA, Food, Labeling, Milk, RecallsFDA

On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers of a recent recall of various fruit beverages. Jonlly Fruits Inc., the manufacturer of the beverages, opted to initiate the …

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FDA Announces Recall of Alfalfa Sprouts After Listeria Monocytogenes is Detected

FDA, Food, Listeria, Recalls, USDAFDA, USDA

On May 8, 2012, the U.S. Food and Drug Administration (“FDA”) announced the recall of alfalfa sprouts produced by the company Cleveland Beansprouts Co. Discussed here, the Company is recalling the sprouts due to the possible contamination with Listeria monocytogenes. …

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More Recalls of Pet Food in Wake of Salmonella Detection

FDA, Pet Food, Pet foods, Recalls, SalmonellaFDA

The U.S. Food and Drug Administration (“FDA”) has announced the recall of additional pet food due to the detection of Salmonella. According to the FDA, WellPet LLC initiated the voluntary recall as a result of the bacteria being found in …

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FDA Explains its Regulation of Bottled Water

Beverages, Bottled Water, CGMP, FDA, LabelingFDA

Recently, the U.S. Food and Drug Administration (“FDA”) published “Food Facts”, a document providing the public with information concerning the Agency’s regulation of bottled water. Found here, the document details how the Agency works in conjunction with the Environmental Protection …

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FDA Approves New Orphan Drug (Elelyso) to Treat Gaucher Disease

Drugs, FDA, Gaucher disease, Orphan Designation, Orphan DrugFDA

On May 1, 2012, the U.S. Food and Drug Administration (“FDA”) approved a new orphan drug to treat Gaucher disease. The drug, Elelyso (taliglucerase alfa), is an injection therapy used for enzyme replacement in people with the rare genetic disorder. …

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FDA Approves Drug for Treatment of Plague Through Animal Efficacy Rule

Animal Efficacy, Drugs, FDA, Labeling, NDAFDA

On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk …

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    Katherine L. Giannamore
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